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Outstanding article on RXII on Seeking Alpha
http://seekingalpha.com/article/3121906-rxi-pharmaceuticals-one-undervalued-biotech-that-keeps-building-its-pipeline-for-future-value
INSIDER INFORMATION: does it both any of you that all this week the stock was trending down instead of what you'd expect (upward) that information leaked out.
Why did the stock come down from the recent $3.30 range. It just kept coming down. Then this past week when everyone was expecting it to go up, it went down. WHY?
Obviously a lot of people had been warned.....had insider information before 4/17.
Same old story in the stock market. There is much more insider information that most people might think.
Like Yogi said, "It ain't over till it's over"
It should be noted that tPA and surgical removal of brain blockage ARE NOT COMPETING THERAPIES FOR MULTISTEM.
These therapies target limiting the primary injury while MULTISTEM targets the secondary injury caused by inflammation.
So these therapies can be used together. In fact the phase 2 ischemic stroke study of MultiStem allows for the inclusion of tPA and mechanical perfusion.
We are all aware of Athersys' recent partnership of Chugai. I am assuming that Chugai did an awful lot of due diligence before inking an agreement with ATHX and giving ATHX such an excellent deal.
Chugai certainly did more DD than any individual investor is capable of doing and may have had privy to some information not available to a private investor.
Draw your own conclusions.
Remember that this week's downward spiral of PPS has nothing to do with the results to be announced this Sunday. Investors are sheep and they follow the crowd. The price starts to dip (maybe with the help of market makers) and investors are scared out of their socks.
With all that I have read, I believe Athersys is on to something in terms of reducing the inflammation caused by the spleen. I'm betting the results are going to be very good. My money is on the line. I've done my own DD. You did yours and now we wait and see.
RE: MY POST #1292....to clarify further
So in ATHX's phase 2 trial for I.S.
if the percentage of MultiStem patients that show meaningful improvement exceeds the placebo group by about 12% or better, WE HAVE A WIN FOR ATHX because MultiStem can be given 24-48 hours post stroke versus only 3-4 hours post stroke for tPA (current standard of care).
Now what if the MultiStem group exceeds the placebo group by say 15-20% or better?
Now you have better efficacy plus a much longer window to treat stroke patients.
This could lead Wall Street to conclude that MultiStem is probably going to become the new standard of care for ischemic stroke (a $15 BILLION MARKET only counting the U.S., Europe and Japan.
Even though ATHX will almost certainly partner with bigger companies and receive milestone payments plus royalties, their eventual revenue could easily exceed $1 Billion annually. And this is just for the ischemic stroke indication.
i.e. Wall Street could value ATHX at several BILLION DOLLARS; maybe not immediately but in time.
That is what we could be looking at beginning Monday morning.
CRITICALLY IMPORTANT IF YOU OWN ATHX
From Edison Investment Research Limited
Athersys is a research client of Edison
This is from a Jan 12, 2015 research report
(((this is the criteria for success in ATHX's Phase 2A in Ischemic Stroke)))
The rest below is a direct quote:
Aside from a safety assessment, the PRIMARY ENDPOINT will measure relative changes between MultiStem and placebo groups in three widely accepted stroke scales: functional disability (modified Rankin Score), neurological deficit (NIH stroke scale) and activities of daily living (Barthel Index).
The primary focus of the study is to evaluate the relative difference in outcomes with regard to improvement among patients that have received MultiStem or placebo. Patients in the study are moderate to severely affected stroke patients and the aim is to evaluate good to excellent outcomes.
The global assessment (using the three stroke scales) should therefore provide a more complete picture in terms of the improvement across cognition, motor skills and activities of daily living. The proportion of patients receiving MultiStem that show a clear and meaningful improvement in HIHSS, mRS and Barthel, will be compared to the same improvement percentage in the placebo group. Should that absolute difference in response rates between MultiStem and placebo be equal to or greater than that observed with tPA (11-20% on excellent outcomes in the Activase NINDS studies), while extending the treatment window to 2-3 days over the current 3-4 hours, MultiStem's potential as an important new therapeutic option for ischemic stroke would be confirmed.
TABLE
Activase NINDS t-PA stroke trial, Part 2 (90day efficacy outcomes
Frequency of Favorable Outcome*
Placebo (n = 165) Activase (n = 168) Difference
Barthel Index 37.6% 50% 12.4%
Rankin Score 26.1% 38.7% 12.6%
NIHSS 20.0% 31% 11.0%
MY COMMENT: IF MULTISTEM IS THIS GOOD OR BETTER (ALONG WITH GOOD SAFETY) THEN IT HAS A GOOD CHANCE OF EVENTUALLY BECOMING THE STANDARD OF CARE FOR ISCHEMIC STROKE DUE TO THE FACT IT CAN BE GIVEN 24-48 HRS POST STROKE.
THAT'S IT FOLKS. THIS IS WHAT SPELLS SUCCESS FOR US THIS SUNDAY (IN 3 DAYS)
I can't believe this low volume and price action.
Go easy on the drugs RichDude. Do you ever post more than one liners?
We need much more volume...like 10 million shares traded!
Why the PPS is down....my guess
People don't see upcoming catalysts but they do see the need for financing.
But the big surprise to everyone could/would be a sudden PR out of left field
announcing a major worldwide exclusive partnership with BAXTER who
is also working on something very similar to NBS-10 post heart attack.
I would think that could possibly double the PPS overnight. It might even do
better than that.
Other than a partnership, what other catalysts are coming in the next six months???
IMO fear of financing has brought it from $4 to $2.40 recently.
I bought a bunch @ $2.40 and sold it @ $2.85.
I'm hoping it drops down to around $2.50.
I half expect a partnership with Baxter anyday now. That's all.
Re: Athersys, a client of Neostem....
If the Athersys Stroke Trial is successful (they are announcing the results of their Phase 2A Ischemic Stroke Trial on Sunday, April 19th) they will need a lot more of their Multistem and I would guess that means a lot more business for Neostem. A LOT MORE.....for Japan soon (hopefully).
Once these clients have approved products, Neostem revs should increase significantly.
I only reposted this
so that more people would see it.
If you post in BOLD and mention it is a PR
more people will read it. Also important to post
MEDI-CAL REIMBURSEMENT.
IF READERS SKIP OVER THE POST IT DOES NO GOOD.
PR 4/7/15: GPS SmartSoles Approved for Medi-Cal Reimbursement
GPS SmartSoles Approved for Medi-Cal Reimbursement
GTX Corp Approved As A Vendor Throughout All 21 Regional Centers In California Coordinating Services For Intellectually and Developmentally Challenged Persons From Birth On, Including Adults With Alzheimer’s And Dementia.
LOS ANGELES, CALIFORNIA APRIL 7, 2015 – GTX Corp. (OTCBB: GTXO), a pioneer and global provider of personal location wearable technologies, announced that its flagship GPS SmartSoles have been approved for 100% reimbursement under the Medi-Cal program. Medi-Cal is California’s Medicaid program, financed equally by the State and Federal government which provides a public health insurance program and health care services for low-income individuals and families who meet defined eligibility requirements. The Medi-Cal program includes 58 county public social services agencies and 21 regional centers.
“Receiving our first State and Federal funded reimbursement code for this product is a significant step forward for us,” commented Patrick Bertagna, Chief Executive Officer of GTX Corp. “With the retail price of the GPS SmartSoles and monthly monitoring service having been approved as reasonable and customary, eligible individuals will be able to obtain our GPS SmartSoles and service under the program with no cash out of pocket. The ability to offer GPS SmartSoles to the public who needs them without cost being an issue is important for us and the current 11.3 million Californians, roughly 30% of the State's population, enrolled in the program. This is a game-changing catalyst for GTX, and should open the doors wide open to the millions of people who need this solution but otherwise could not afford it and represents a first in many steps to have the GPS SmartSoles covered by other State funded programs, private insurance, and ultimately by Medi-Care.”
The wearable but not visible, stigma free GPS SmartSoles were designed to assist caregivers of persons with Alzheimer’s, dementia, autism, and other cognitive memory disorders in tracking their loved ones in the event that they wander off, while preserving their dignity and safety by not branding them with a visible bracelet or pendent. The GPS SmartSole is a shoe insole that has been designed with the latest GPS and cellular tracking technologies, enabling a caregiver to know the whereabouts of their loved one with a click of a mouse or push of a button.
GTX Corp has become an approved vendor across all twenty-one Regional Centers under the Department of Developmental Services as part of the State of California Health and Human Services Agency Medi-Cal program. As part of an ongoing initiative for staff members of these twenty-one regional facilities to become more aware of the products and services made available to the community, GTX Corp has been invited to attend The Westside Regional Centers Semi-Annual Staff Resource Day on April 30, 2015 to demonstrate and familiarize their staff with the GPS SmartSoles and their benefit to the community.
Anthem Blue Cross Partnership Plan and Anthem Blue Cross also administers a Medi-Cal program for the California Department of Health Services. Anthem Blue Cross is contracted with L.A. Care Health Plan to provide Medi-Cal Managed Care Services in Los Angeles County. Anthem’s program's primary features include improved access to care, an emphasis on prevention, increased provider participation, a shift from episodic to primary care, and premier customer service, a design that has become the foundation for their programs in other states.
About GTX Corp
GTX Corp (GTXO) is a pioneer in wearable technology and a leader in enterprise 2 way GPS real-time personal location based services. Headquartered in Los Angeles, California, GTX began marketing its SmartSoles less than a year ago and already has distribution in 9 countries. The Company is known for its game-changing and award-winning patented GPS Smart Shoe, blockbuster Smartphone GPS Tracking App, and innovative GPS SmartSole, GTX provides solutions that answer the "where" question: where is my mother, child, employee, vehicle, drone and high value assets.
Through a robust global enterprise monitoring platform and licensing subscription business model, the Company offers a complete end to end solution of location based hardware, middleware, apps, connectivity and professional services. Letting you know where or how someone or something is at the touch of a button, delivering security and peace of mind in an instant. GTX Corp also owns and operates LOCiMOBILE, Inc which develops applications for smart phones and tablets and Code Amber Alertag. The Company has a comprehensive intellectual property strategy and owns an extensive portfolio of patents, patents pending, registered trademarks, copy rights and URL's and was recently featured in a 38 page research piece which outlines the value proposition of the Company’s IP portfolio.
Online: www.gtxcorp.com www.gpssmartsole.com
Social media - #withyou
https://www.facebook.com/gtxcorpcom
http://www.twitter.com/gtxcorp
http://www.pinterest.com/GTXCorp/
http://instagram.com/gtxcorp
General information, licensing or investor relations email:
info@gtxcorp.com
213.489.3019
http://www.gtxcorp.com/about/licenseinquiry
ir@gtxcorp.com
Disclaimer: GTX Corp does not warrant or represent that the unauthorized use of materials drawn from the content of this document will not infringe rights of third parties who are not owned or affiliated by GTX Corp. Further GTX Corp cannot be held responsible or liable for the unauthorized use of this document’s content by third parties unknown to the company.
Forward Looking Statements
This news release contains forward-looking statements. The terms and phrases “expects”, “would”, “will”, “believes”, and similar terms and phrases are intended to identify these forward-looking statements. Forward-looking statements are based on estimates and assumptions made by GTX in light of its experience and its perception of current conditions and expected future developments, as well as other factors that GTX believes are appropriate in the circumstances. Many factors could cause
GTX’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Certain risk factors that may cause actual results to differ are set forth in GTX’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (which may be obtained at http://www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on GTX’s forward-looking statements. GTX has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
# # # #
This is a promotional message from GTX Corp, Inc. 117 W 9th Street Los Angeles, CA 90015 Copyright © 2015 All rights reserved. The GPS Tracking Devices are members of the GTX Corp family of products and services (GTXO).
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The choice is:
Do you invest in a company where you can trust the CEO or one where you cannot trust the CEO.
All other things being equal, which company do you invest in?
There are lots of biotechs that have great science and a track record of being on trial with projections and getting good results.
Hoping the FDA gives approval for patients over age 60
What will the share price be on Friday, April 17???
In just over 3 weeks we will know what we've got.
Will shares take a dive down to say $1.00 - 1.50
or skyrocket up to $8-15 or higher?
Just think how much money is riding on this cumulatively (all investors not to mention the future of Athersys).
If the results are good, I sure hope the results are definitive and outstanding.
If so, think of the institutional money that will pour into this investment.
And think of all the other indications ATHX is currently working on and will be able to begin working on.
I am hoping that the results blow away the Phase 3 results seen with rtPA.
What I'd give to be able to see 24 hours into the future as an investor in the stock market. That's my fantasy. Imagine the money you could quickly make if you could know the results of all the trials just 24 hours in advance of the PRs that go out. Oh my. Dream on baby!
Zack's Research Report - Update 3/23/15 for Enumeral (LINK)
http://scr.zacks.com/files/March-23-2015_ENUM_Napodano_v001_u8wjpr.pdf
LINK TO CANF ANNUAL REPORT.....just came out
http://ir.canfite.com/all-sec-filings/content/0001213900-15-002133/0001213900-15-002133.pdf
Upcoming CATALYSTS for NWBO:
Other Upcoming Catalysts for Northwest
The principal purpose of this report is to discuss the new reported data on DCVax-L. However, I did want to highlight a number of potential upcoming catalysts for the stock:
Northwest may complete the process of negotiating reimbursement with ten hospital groups in Germany in the coming months. This will be followed by actual product sales.
The Company will begin two phase 2 trials with DCVax Direct in 1H, 2015. There are no approved treatment options in the case of inoperable tumors and the FDA would move swiftly if the data is positive. As in the case of Kite and Juno, these could be the basis of a regulatory submission seeking accelerated approval assuming success. If so, commercialization could begin in 2017.
An analysis of the full data set for the phase 1 trial of DC Vax Direct should be released in the next several months. Final data on the last patient may be available in April, 2015. This may not allow enough time for an ASCO presentation in June.
The final part of the UK Promising Innovative Medicine designation should be completed and DCVax-L approved for commercial use in the UK in several months.
There could be collaboration with one of the checkpoint modulator developers, likely Merck or Bristol-Myers Squibb, to combine their products with DCVax-L or DCVax Direct.
The first interim analysis that is triggered by 149 events could be completed for the DCVax-L phase 3 trial at any time. I do not expect the trial to be stopped for efficacy. I think that the data monitoring committee will simply recommend that the trial continue.
I expect topline data on the DCVax-L phase 3 study in 1H, 2016.
The available stock for shorting has been greatly diminished by the shorting that has taken place and the buying of the stock by strong institutional hands. There are 9 million shares short and as many as 4 million naked shorts. The situation is ripe for a major short squeeze.
I disagree with you Austin. IMO Larry Smith tries to be very even handed in his reports. He reports the positives and negatives, regardless of the stock. But when the results are this good, he says so with the usual disclaimers because we all know nothing is a sure thing.
I've seen so many trials have positive results but miss slightly on the primary endpoint. Then they use a different endpoint and have success in phase 3.
Some recent examples of companies who had positive Phase 2 results but got slammed anyhow:
TNXP, NBS, CUR. All 3 had overall very good results but missed on primary endpoint. I believe all three of these will end up getting good results in their phase 3 trials.
Smith On Stocks has this to say re: yesterday's results...[/b
This is just the opening of a much longer article:
Northwest Biotherapeutics: Promising New Data Was Just Presented on DCVax-L in Recurrent Glioblastoma Multiforme (NWBO, Buy, $7.29)
POSTED by LARRY SMITH on MAR 27, 2015 • (1)
Executive Summary
Northwest Biotherapeutics has just presented data on 51 patients whom investigators originally intended to enroll in the ongoing, critically important, 348 patients phase 3 trial of DCVax-L in newly diagnosed glioblastoma multiforme. They became ineligible when their cancer progressed before they could enter the trial. However, they were treated nearly identically to the 348 patients and followed to see how long they survived; the survival data was striking. This increases the expectation for success in the ongoing phase 3 trial.
Glioblastoma multiforme is the most deadly form of brain cancer. If unchecked, it grows rapidly in the narrow confines of the skull and begins to interfere with bodily functions controlled by the brain. In advanced cases it actually begins to push the brain into the brainstem that connects the brain and spine. The current standard of care is based on surgery removing as much as the tumor as possible and then treating with radiation and chemotherapy. In almost all cases, the tumor begins to regrow and when it does clinical studies show that 50% of patients die within about 9 months. There is no approved drug that has shown it can increase survival in these recurrent glioblastoma patients. These 51 patients were primarily this type of desperate patient.
There were 20 of these 51 patients who were classified as rapid progressors. Even within recurrent glioblastoma, these patients are probably the sickest of the sick. Half of these patients treated with DCVax-L lived 15.3 months or more which represents an improvement of about 6 months when compared to median survival seen in historical studies. Generally, a 4 to 5 month improvement in an aggressive cancer like this is considered a major advance.
There was also survival data for another 25 patients who were in a better state than the rapid progressors but still much sicker than the vast majority of GBM patients. Half of these patients lived longer than 21.5 months. To put this in perspective, this is an impressive result even if compared to survival expectations for much healthier newly diagnosed patients whose survival expectation is that half will live more than 15 to 17 months. This is almost as striking as the results seen in the 20 rapid progressors.
I'm anxious to read Larry Smith's take on today's news....
SmithOnStocks will surely comment by tomorrow morning as to his take on the results reported this morning and I am anxious to read his views.
He is more experienced at this biotech investing than any of us.
We'll see tomorrow.
You have to figure Roche/Chugai did way more DD than any of us could possibly do!!!
If Roche/Chugai made an investment/commitment to Multistem/Athersys, that really says more than any article on S.A. or anybody posting here on Investors Hub.
It says all you need to know. This is NO GUARANTEE but it builds confidence in investing yourself.
I already had 26,000+ shares bought @ around $1.40 that I sold @ $3.20 recently. Then I was kicking myself as ATHX went over $3.30.
I never thought it would come down as much as it did this week.
At $2.70 I had to pull the trigger and buy back in (27,380 shares).
Plan to sell a bunch @ $4.00 roughly and then let the rest ride and pray for the best!
New S.A. article re: Athersys. Here is the link to read it.
http://seekingalpha.com/article/3031446-date-and-time-is-set-for-athersys-phase-ii-stroke-presentation?app=1&auth_param=s4hu7:1ah8jqs:09a877cba2d69dc28c4d4eff919bff4f&uprof=46&dr=1
Date And Time Is Set For Athersys Phase II Stroke Presentation
Mar. 26, 2015 2:25 PM ET | About: Athersys, Inc. (ATHX)
Disclosure: The author is long ATHX. (More...)
Summary
Phase II Stroke Data to be Presented April 19th 8:50 AM in Glasgow, UK.
Recent Weakness Represents a Better Entry Point.
The Science Behind the Stroke Trial is Substantial.
Although there has been no formal press release by Athersys (NASDAQ:ATHX), the exact time and date of its highly anticipated stroke results has been set. The data will be presented for April 19th at 8:50 local time in Glasgow, UK at the European Stroke Orginisation Conference 2015. Here is a copy of the program details along with the link:
SCIENTIFIC PROGRAMMESC18 Scientific Communications (Oral Abstract Presentations)
CLINICAL TRIALS
19-Apr-2015 08:30 10:00
Abstract:
RESULTS OF THE DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PHASE 2 SAFETY AND EFFICACY TRIAL OF MULTISTEM® IN ADULTS WITH ISCHEMIC STROKE
BACKGROUND: MultiStem® is an adult, adherent, stem cell product, having shown safety and efficacy in other clinical indications. We assessed whether it was safe and improved functional outcome in patients with ischemic stroke.
METHODS: This was a double-blind, placebo-controlled trial of ischemic stroke patients (NIHSS 8-20, inclusive) treated within 24-48 hours of symptoms at 33 U.S. and U.K. sites. Following a dose escalation phase, patients were randomized 1:1 to receive intravenous infusion of MultiStem® or placebo. The primary efficacy endpoint was Global Stroke Recovery at Day 90 (a test statistic combining modified Rankin Scale =2; NIHSS total score improvement of =75% from baseline; Barthel Index =95) in the MultiStem group compared to placebo group. Secondary and exploratory efficacy endpoints included: modified Rankin Scale by shift analysis at Day 90, changes in cortical infarct volume measured by MRI, and changes in blood markers (white blood cell populations and cytokines) from baseline to Day 30. Safety end points included adverse events or neurologic worsening through 7 days post-infusion, the incidence of secondary infections, differences in adverse events, mortality and vital signs through Day 365 between the treatment groups.
RESULTS: Patients were enrolled from November, 2011, to December, 2014. In the dose escalation phase, both doses were well tolerated and safe and the high dose of 1200 million cells was chosen. 126 patients formed the modified Intention To Treat population, 65 receiving MultiStem®, 61 receiving placebo. Results on the primary, secondary and exploratory efficacy and safety outcomes will be presented during the conference.
Co-authors
D.C. Hess1, W.D. Clark2, D. Chiu3, L.R. Wechsler4, K. Uchino5, A.P. Auchus6, C.A. Sila7, A.J. Furlan7, J.A. Switzer1, R.W. Mays8.
1Neurology, Georgia Reagents University, Augusta, USA.
2Neurology, Oregon Health Sciences University, Portland, USA.
3Neurology, Houston Methodist, Houston, USA.
4Neurology, University of Pittsburgh Medical Center, Pittsburgh, USA.
5Neurology, Cleveland Clinic, Cleveland, USA.
6Neurology, University of Mississippi, Jackson, USA.
7Neurology, Case Western Reserve University Hospital, Cleveland, USA.
8Regenerative Medicine, Athersys Inc., Cleveland, USA.
eso.kenes.com/scientific-programme/scientific-programme-2#.VRQKxvnF-T8
My thoughts and extensive research on this trial can be found in the following articles on Seeking Alpha and there is no need to rewrite these thoughts again:
Athersys Down But Not Out - An Interview With CEO Van Bokkelen
Athersys Could Benefit Immensely From Japan Reimbursement On Stroke
It is my position that the weakness in the biotech sector over the last couple of days presents a great opportunity for investors to establish a position, as Athersys shares have declined sharply from recent highs. I do not believe the backtracking in shares has anything to do with the stroke results, which according to Athersys, are to be unblinded shortly before the conference. However, this is not an investment for those who do not understand the risk or perform their own due diligence.
There are those who are playing the short side of this trade ahead of the results, and they like to play on these fears and point to the failure of MultiStem in showing efficacy in an ulcerative colitis trial run by Pfizer. Although there doesn't seem to be a big short contingent, as the cost to borrow shares has not changed much over the last few weeks and now sits at about 4.75% with about 550,000 shares available at Fidelity, one of the "concerns" I have seen put out there by the short side is that any efficacy at 30 days may not be sustainable at 90 days (the primary endpoint for the trial). Based on the mechanism of action, if MultiStem improves patient outcomes at 30 days, this improvement will not likely be lost at 90 days. The basis for this belief is the pre-clinical research that shows that the first week following a stroke is the period of time when much damage is done to the brain by the over inflammatory response of the spleen. The role of the spleen is also confirmed in this research in actual stroke patients. The spleen's overreaction is mitigated by MultiStem by shutting down the brain/blood barrier. Once the patient gets beyond this stage, the neurotrophic factors start to kick in and hopefully provide further benefit, as some level of healing takes place and new blood vessels begin to form. By the 30th day the bulk, if not all, of the potential secondary damage threat from the spleen has passed. So there is little reason to believe that improvement at 30 days would not be sustainable at 90 days.
Stroke is an acute injury and not comparable to ulcerative colitis, a chronic systemic disease that may need multiple dosing to get over the hump. Although we can't know for sure if multiple doses would have worked for ulcerative colitis until another double blinded placebo controlled trial is commenced.
The stakes are high here, not only for investors but for stroke patients and the regenerative medicine field, in general. Recently Chugai Pharmaceutical Co., Ltd. paid Athersys $10,000,000 up front for the exclusive rights to market MultiStem for stroke in Japan in a deal worth about $195,000,000 in milestone payments and generous royalties to Athersys based upon success. Chugai is a subsidiary of major Swiss based pharmaceutical company Roche and has been involved in talks with Athersys for over a year before pulling the trigger. The scientists at Chugai have surely done an incredible amount of due diligence on this therapy.
It is human nature to look at every move up and down in the share price as a validation or a warning for shortly upcoming clinical results and short sellers are certain to try and prey on this fear when shares decline in advance of results. No one can guarantee a positive outcome but I remain long and optimistic. We will all have the answers no later than 4:50AM EST on April 19th.
And OS will continue to increase as those living continue living.
So in one year the OS will be that much longer. And what if the majority of those living today are still living one year from today?
This would be almost impossible with no treatment or any other drug treatment.
The current MC for CYNAF is about $82M @ 93 cents/share, so
if the company was acquired for $750M, that would be 9.14 x the current MC of $82M.
At $1B, that would be 12.2x the current share price or $11.34 per share.
Either way, this could all happen once the company is ready to apply for
an NDA in 12-18 months.
My guess, CYNAF is acquired in 2016 for est. $750M - $1B
Compare that to today's market cap!
What the Phase 2 Ischemic Stroke Trial needs to show!!!
From Edison Research Report dated January 12, 2015
The following is a quote from the report:
Aside from a safety assessment (rate of dose limiting adverse events after seven days), the primary endpoint will measure relative changes between MultiStem and placebo groups in three widely accepted stroke scales: functional disability (modified Rankin Score), neurological deficit (NIH stroke scale) and activities of daily living (Barthel Index).
The primary focus of the study is to evaluate the relative difference in outcomes with regard to improvement among patients that have received MultiStem or placebo. Patients in the study are moderate to severely affected stroke patients and the aim is to evaluate good to excellent outcomes. The global assessment (using the three stroke scales) should therefore provide a more complete picture in terms of the improvement across cognition, motor skills and activities of daily living. The proportion of patients receiving MultiStem that show a clear and meaningful improvement in NIHSS, mRS and Barthel, will be compared to the same improvement percentage in the placebo group. Should that absolute difference (delta) in response rates between MultiStem and placebo be equal to or greater than that observed with tPA (11-20% on excellent outcomes in the Activase NINDS studies), while extending the treatment window to 2-3 days over the current 3-4 hours, MultiStem's potential as an important new therapeutic option for ischemic stroke would be confirmed. End Quote
That's it folks! If MultiStem is equal or better than the above tPA results, Athersys could be on the way to becoming the new worldwide standard of care for ischemic stroke.....a $15 Billion market in just the U.S. Europe and Japan.
Considering the size of the I.S. market, if the Ph2 news is excellent, it is easy to imagine the stock being revalued to around $1 Billion market cap.
Seems reasonable with the market being in excess of $15 Billion.
I would love to see results that are superior to rtPa phase 3 results.
Considering the time advantage (ATHX's trial is administering Multistem 24-36 hrs post stroke) if Multistem shows the same or greater benefit vis a vis rtPa, then we have a winner here.
Regarding "Analyticals"....
We have all know highly intelligent people who had 4.0 GPAs in high and/or college.
They could even be Phds.
But they could never start a business and succeed.
They are book smart. They can memorize and regurgitate information but they cannot put things together in the real world and succeed in business or as investors.
Then there is the high school graduate with his/her "C" average. They start a business and build it into a big successful business. They were popular in school because people related to them. They had people skills, self confidence and a certain way of getting things done.
I'll always take the person with high scores in "common sense" over the book smart person.
Regarding "Analyticals" again....
THIS SUMMARY SAYS IT ALL: Click on the link....
http://nwbio.com/NWBT_ITOC_poster_3-25-15.pdf
"Analyticals versus "Common Sense"
Analyticals are people who are fact driven. They are known to over analyse everything.
They get so caught up in minutiae they can't see the forest through the trees.
You can never show an "Analytical" enough facts. They always want more and eventually they confuse themselves to the point that they cannot make a sensible decision.
I've seen this over and over again in my 35 years in business.
Give me a person with common sense anytime. Someone who gets the pertinent facts and can make a common sense decision.
Now one thing we should all ask ourselves this morning is this:
Do you think NWBO was making this presentation because they thought it was "discouraging" information that would discourage investors from investing? I think not.
Clearly THEY thought this information was quite encouraging and "unheard of" in terms of historicals.
RESULTS seem rather impressive to me. Many posters here
like to flaunt their knowledge. Some could get confusing explaining 2 + 2 = 4.
I'm not a biochemist or a Phd or MD but these results seem very impressive to me.
NWBO treated these patients who were living on borrowed time. These were the worst of the worst. Mind you, they were so bad off they did not qualify to be in the "L" phase III trial.
So NWBO treats them on a compassionate basis and their OS blows historicals away.
How is that a bad thing. Some of these patients should have been dead a long time ago and they are still alive.
Some of you just love to complicate things that are pretty obvious to us "less smart" investors.
Help me out pls: What does the "e" stand for in ePD (progressive disease)? TIA
ATHX VP Finance Laura Campbell says Phase 2 data will be released at .....
the April conference (April 17th - 19th) and the PR will go out at the same time the info is being presented.
I hope I am remembering her name correctly. She called while I was driving. I had called about 2-3 weeks ago and she was finally getting back to me.
MUST READ ARTICLE by Stock Doctor on Seeking Alpha. Click on LINK here....
http://seekingalpha.com/article/3024216-mei-pharma-upcoming-catalysts-will-drive-stock-rebound?app=1&auth_param=s4hu7:1ah2ugb:9d10dff35f26c267561010dcb5fe286d&uprof=46&dr=1
Pretty surprising the trial results were so diff from previous results.